PDF: PAUSE TAVI
(2025)Objective
Periprocedural continuation vs interruption of DOAC during TAVI in terms of cardiovascular and bleeding events within 30 days.
Study Summary
Intervention
Periprocedural continuation vs. interruption of oral anticoagulation (VKA or DOAC) in patients undergoing TAVI.
Inclusion Criteria
Patients undergoing TAVI with long-term indication for oral anticoagulation; excluded if recent stroke/TIA, mechanical valve, recent VTE, or intracardiac thrombus.
Study Design
Arms: Continuation of Anticoagulation vs. Interruption of Anticoagulation
Patients per Arm: Continuation: 431, Interruption: 427
Outcome
Bottom Line
In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation of anticoagulation was not non-inferior to interruption with respect to the primary composite outcome at 30 days. This was driven by a higher incidence of bleeding complications in the continuation group with no significant difference in thromboembolic events.
Major Points
- One-third of patients undergoing TAVI have an indication for oral anticoagulation owing to concomitant diseases.
- This was an international, open-label, randomized, noninferiority trial.
- The primary outcome occurred in 16.5% of the continuation group and 14.8% of the interruption group, failing to meet the noninferiority criterion.
- Any bleeding occurred in 31.1% of the continuation group versus 21.3% in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).
- Thromboembolic events were similar between the groups, occurring in 8.8% of the continuation group and 8.2% of the interruption group.
- The findings provide evidence supporting periprocedural interruption of oral anticoagulation in patients undergoing TAVI.
Study Design
- Study Type
- International, investigator-initiated, open-label, randomized clinical trial with blinded outcome assessment.
- Randomization
- Yes
- Blinding
- Open-label with blinded outcome assessment by a clinical-events committee.
- Sample Size
- 858
- Follow-up
- 30 days.
- Centers
- 22
- Countries
- Netherlands, Belgium, Denmark, Italy, Ireland, Luxembourg
Primary Outcome
Definition: A composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding (VARC-3 type 2, 3, or 4) within 30 days after TAVI.
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 14.8% (63/427) | 16.5% (71/431) | - (-3.1 to 6.6 (Risk Difference) ) | 0.18 for noninferiority |
Limitations & Criticisms
- This was an open-label trial and was thereby potentially subject to reporting and ascertainment biases, although trial outcomes were adjudicated by a blinded clinical-events committee.
- The pragmatic nature of the trial did not include a neurologic examination or neuroimaging in all patients.
- The trial was powered for a composite primary outcome, so no clinical inferences should be drawn regarding the separate components.
- Almost all the patients enrolled were treated with the use of the transfemoral approach, so the results should not be generalized to other vascular-access approaches.
Citation
N Engl J Med 2025:392:438-49